MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Loss of Range of Motion (2032)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Year of birth: (b)(6).Concomitant medical products: 00596801452 62038496 lps flex femoral component-option for cemented use only nitrogen hardened size d right.Unknown tibial tray.Report source: foreign country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the provided picture confirms the articular surface post fractured.Sem analysis determined that the post fracture was caused by overloading on the post, exacerbated by potential impingement of the femoral component on the bearing surface at the base of the post, creating a fracture.Primary operative notes do not indicate any intra-op complications.Patient notes state that patient had an injury (twisted trauma) which led to fracture of implant.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.It was reported that the patient twisted her leg and had injury but it is not sure what caused the injury.Hence, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient underwent initial knee arthroplasty.Subsequently, the patient was revised approximately 8 years post implantation due to implant fracture.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11102146
• MDR Text Key: 224590545
• Report Number: 0001822565-2020-04269
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00596203010
• Device Lot Number: 62086442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention